@PhdThesis{duepublico_mods_00027305,
  author = 	{Figulla Dr., Laura},
  title = 	{Evidence on safety and efficacy transcatheter aortic valve implantation or medical therapy in symptomatic severe aortic stenosis: a systematic review of current literature},
  year = 	{2012},
  month = 	{Feb},
  day = 	{17},
  keywords = 	{Aortic stenosis; Transcatheter aortic valve implantation; medical treatment; systematic review},
  abstract = 	{Objectives: Transcatheter aortic valve implantation (TAVI) promises effective treatment for high-risk elderly patients with symptomatic severe aortic stenosis (AS). However, the adop-tion of TAVI must be justified and guarantee long-term performance. Systematic reviews are a core methodology in evidence-based health economics for judging medical effectiveness. In this work, the methodology was applied to provide objective evidence on the efficacy and safety of TAVI at 1-year follow-up and to assess whether TAVI confers a survival benefit compared to  medical therapy.<br>
Methods: In accordance with the toolkit of the ``German Scientific Working Group Technol-ogy Assessment for Health Care'' (GSWG), two independent systematic literature reviews on the safety and efficacy of TAVI procedures and medical therapy of AS were conducted in major bibliographic databases. Preestablished inclusion criteria were defined that were consis-tent for both reviews. For each review, an initial screening of identified articles regarding ti-tles and abstracts was followed by a full-text screening. Data from eligible articles was ex-tracted and evaluated according to GSWG checklists followed by a qualitative synthesis of information.<br>
Results: The systematic literature search identified 12 primary publications (derived from 1,849 citations) for TAVI (number of patients [n]=1,049) and 11 publications (derived from 189 citations) for medical therapy of AS (n=946) that fulfilled the inclusion criteria.<br>
The mean overall procedural success rate for included TAVI interventions was 93.3{\%}. The mean combined procedural, post-procedural, and cumulative in-hospital/30-day mortality was 11.4{\%} (n=116; range 5.3{\%}--23{\%}). For transvascular (TV) TAVI procedures, the mean inhospital/30-day mortality was significantly lower than for transapical (TA) TAVI procedures (9.5{\%} versus 14{\%}) (p-value=0.03). Major vascular complications occurred on average in 3.1{\%} of all patients included in this review, particularly when the TV access route was chosen the incidence was up to 33.3{\%}. Mean incidence of stroke was 4.4{\%}. One year after TAVI, the mean overall survival rate was 75.9{\%} (range 64.1{\%}--87{\%}) compared with 62.4{\%} (range 40{\%}--84.8{\%}) for medically treated patients (p-value<0.0001). One-year survival after TAVI for patients treated with TV procedures was significantly higher than after TA procedures (79.2{\%} versus 73.6{\%}) (p-value=0.041). At 1-year follow-up, the improved valvular function remained stable, and there was a trend towards an improved ventricular function.<br>
Conclusion: Based on the best available data, in patients with symptomatic severe AS, TAVI demonstrates an improved 1-year survival compared with medical treatment. The survival benefit of TV-TAVI over medical therapy elucidated from this systematic literature review is +16.8{\%} and therefore, in good congruence with the recently published results from the ran-domized PARTNER U.S. trial (+20{\%}).},
  url = 	{https://duepublico2.uni-due.de/receive/duepublico_mods_00027305},
  file = 	{:https://duepublico2.uni-due.de/servlets/MCRFileNodeServlet/duepublico_derivate_00029471/Diss_Figulla.pdf:PDF},
  language = 	{en}
}